APHIS Issues Guide to Submitting Reports and Notices in APHIS eFile and Response to Comments

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) is pleased to announce the completion of another resource to help developers navigate the APHIS BRS permit process more efficiently. 

Today, as part of our ongoing work to further clarify and streamline our biotechnology regulations to support Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, we are making available the final version of the Guide to Submitting Data for Reports and Notices in APHIS eFile and the Response to Comments on the draft Guide to Reports and Notices. 

APHIS BRS revised the draft Guide in response to stakeholder feedback to clarify information requirements. The Guide provides specific examples to help developers understand the data requirements and due dates for compliance reports and/or notices submitted using APHIS eFile. The Response to Comments summarizes and addresses the comments BRS received on the draft guide. APHIS BRS continues its work on other deliverables to further clarify and streamline its biotechnology regulations.

• View the Guide to Submitting Data for Reports and Notices in APHIS eFile  (748.02 KB)
• View the Response to Comments on the draft Guide to Reports and Notices  (233.45 KB)